Sumitomo Pharma Co., Ltd. is a leading global pharmaceutical company focused on improving healthcare through innovative solutions in oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. We're committed to accelerating the development of novel therapies to meet patients' needs. Join us in our mission to enhance lives.
This role reports to the Executive Director of Clinical Data Management within the Oncology Data Management team. As an essential member of our clinical development programs, you will play a key role in ensuring the integrity, compliance, and accessibility of clinical trial data.
Key Responsibilities:
• Oversee all clinical data management activities for assigned oncology trials, adhering to ICH/GCP and company SOPs.

• Manage collaborations with CROs and data management vendors, reviewing deliverables and timelines to ensure project success.

• Lead database build processes, manage edit check specifications, user acceptance testing, database modifications, and lock activities.

• Conduct thorough data review, cleaning, query management, and quality control to maintain data accuracy and completeness.

• Create and maintain critical data management documents, including:

• Data Management Plans (DMPs)

• CRF Completion Guidelines

• Data Validation Specifications

• Data Transfer Specifications

• Monitor study metrics (e.g., enrollment, eCRF completion, query aging) to provide regular updates to teams and leadership.

• Collaborate with Clinical Operations, Medical Writing, Biostatistics, and Safety to facilitate data reconciliation and analysis readiness.

• Identify trends and operational risks in data quality and implement corrective actions.

• Support activities related to audit readiness and compliance with regulatory inquiries.

• Ensure adherence to best practices in Data Management.

• Perform additional data management duties to support departmental and organizational objectives.

Qualifications:
• Bachelor's degree in a relevant scientific, health-related, or quantitative discipline.

• Minimum of 4 years of experience in clinical data management within the pharmaceutical or biotech industry, with at least 2 years in a lead role.

• Experience in oncology is preferred.

• Strong knowledge of clinical trial processes, EDC systems, and regulatory requirements.

• Excellent organizational, communication, and analytical skills.

• Attention to detail and problem-solving abilities are essential.

• Ability to work independently and in a collaborative team environment.

The salary range for this position is $130,400.00 - $163,000.00, along with a comprehensive benefits package that includes merit-based salary increases, a 401(k) plan, various insurances, and a generous time-off policy.
Disclaimer: This description is intended to convey general information about the role and is not an exhaustive list of responsibilities or qualifications. All personnel may be asked to perform duties outside of their typical responsibilities as needed.
Compliance: It is critical to maintain adherence to all regulatory and operational requirements in alignment with industry standards and ethical practices.
This position may primarily be remote but may require periodic onsite meetings. Travel requirements may include both domestic and international destinations as necessary.
Equal Opportunity: Sumitomo Pharma America is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to any protected characteristic.